The agency’s Letter to Eye Care Professionals, issued this week, follows a warning from May 2009. In the letter, the FDA says it will give ophthalmologists 90 days to update any advertising or promotional material that makes false claims about LASIK surgery. After that time, the agency will take regulatory action, according to the report.
FDA spokeswoman Erica Jefferson said some physicians do not adequately provide consumers with information about the risks associated with LASIK surgery, including vision loss, under- or over-correction of vision, dry eye, infection, glare, halos and double vision.
The FDA said physicians also make unproven claims and include important omissions, such as saying patients can “throw away their eyeglasses” when, in reality, many LASIK patients still require eyeglasses after surgery.
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